Vertex Pharmaceuticals

Procurement

• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Participates in cross-functional teams as an experienced Quality technical resource
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Initiates and assesses change controls
• Conducts quality investigations /deviations and reviews corrective action plans for adequacy and compliance
• Ensures appropriate CAPA actions are identified and addressed
• Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP) and finished goods (FG) disposition activities
• Maintains Quality Metrics to support process improvement activities
• Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Provides technical advice for partner and regulatory agency audits

Senior GMP Operational Quality Manager – Vendor Management

Program Manager

• Support delivery of program initiatives and project workstreams
• Coordinate testing, validation, training, and change management activities
• Identify operational gaps, analyze root causes, and recommend process improvements

Extended Workforce Program Operations Lead

• Track and report GCP privacy events within RDQ in accordance with established procedures and workflows.
• Manage a shared Privacy mailbox and related correspondence, ensuring timely tracking and follow up of related items.
• Support Privacy Event Management, including initial assessments, guidance through resolution, and documentation to closure.
• Analyze privacy risks and help implement appropriate mitigation strategies.
• Provide documentation and coordination support to the RDQ Governance & Risk Management team.
• Design, build, and maintain a centralized SharePoint site for the RDQ Governance & Risk Management team.

R&D Quality Coordinator, Privacy & Risk Management

Events

• Track and report GCP privacy events within RDQ in accordance with established procedures and workflows
• Manage a shared Privacy mailbox and related correspondence, ensuring timely tracking and follow up of related items
• Support Privacy Event Management, including initial assessments, guidance through resolution, and documentation to closure.
• Analyze privacy risks and help implement appropriate mitigation strategies.
• Identify trends and triage effectively within RDQ and according to established procedures.
• Maintain accurate records and status tracking to support reporting, oversight, and inspection readiness.
• Provide documentation and coordination support to the RDQ Governance & Risk Management team
• Support development, documentation, and maintenance of RDQ processes related to governance and risk management
• Support preparation and organization of materials for risk reviews and governance discussions.
• Design, build, and maintain a centralized SharePoint site for the RDQ Governance & Risk Management team.
• Develop and maintain resource pages, including process overviews, templates, FAQs, points of contact, and escalation guidance.

Quality Privacy Event Processing and Documentation Coordinator – Contract

• Develop and maintain an integrated OCM plan for Quality transformation programs.
• Develop and maintain a portfolio-level view of OCM demand, priorities, risks, and resource needs across multiple Quality transformation initiatives.
• Translate project scope, timeline, document changes, system releases, and process changes into a clear adoption roadmap.
• Define OCM activities by change impact level: low, medium, high, and transformational.
• Integrate OCM milestones into the broader project plan and phase gate process.
• Identify adoption risks early and recommend mitigation actions.
• Build stakeholder maps across Quality, Manufacturing, Labs, MSAT/ASAT, Regulatory, Technical Operations, Data, IT, Training, and external partner teams as applicable.
• Conduct role-based change impact assessments.
• Identify changes to responsibilities, decision rights, review behaviors, escalation paths, data usage, system interactions, and governance.
• Group impacted populations by level of change and required OCM support.
• Identify where new or updated SOPs/WIs require additional behavior change, training, communications, or manager reinforcement.
• Support sponsors and senior leaders in articulating the case for change.
• Develop sponsor talking points, leadership messages, and reinforcement actions.
• Help leaders understand where visible sponsorship is required to reduce resistance and drive adoption.
• Prepare leadership updates for program governance and Steering Committee forums.
• Develop targeted communication plans for impacted stakeholder groups.
• Create practical messaging that explains what is changing, why it matters, who is impacted, what actions are required, and when.
• Support SME briefings, roadshows, office hours, FAQ development, manager toolkits, and readiness sessions.
• Ensure communications are aligned with the project timeline, document effective dates, training deployment, and go-live waves.
• Partner with Training, Quality Systems, process owners, and SMEs to ensure training is role-based and tied to actual future-state execution.
• Identify where training alone is insufficient and where coaching, walkthroughs, job aids, or readiness checks are needed.
• Support go-live readiness assessments across people, process, technology, data, documents, and support model.
• Define readiness criteria for each go-live wave.
• Define 30/60/90-day sustainment plans after go-live.
• Establish adoption metrics, feedback loops, issue escalation paths, and business-as-usual ownership.
• Monitor adoption risks, behavior drift, workarounds, and inconsistent execution.
• Ensure lessons learned are captured and fed into future phases and programs.

AD/Director – Organizational Change Management Lead – Quality Transformation Portfolio

ServiceNow

• Design and develop ServiceNow ITOM solutions including Discovery, Service Mapping
• Integrate ServiceNow with Microsoft Azure for cloud resource discovery, monitoring, and automation
• Develop and maintain custom scripts, workflows, and integrations using ServiceNow APIs and Azure services
• Configure MID Servers and ensure reliable connectivity for on-prem and cloud environments
• Optimize performance, scalability, and reliability of ITOM and Azure integrations
• Support incident resolution, root cause analysis, and continuous improvement initiatives
• Document technical designs, configurations, and operational procedures

Azure ServiceNow Developer – Contract

Data Analyst

• Deliver PMO and Project Management support for POVE Commercial Analytics
• Robust project planning and governance to ensure cross-functional teams are coordinated
• Integrated project planning, RAIDD management, and weekly status reporting
• Cross-team dependency management and proactive escalation

Commercial Operations and Analytics Program Manager – Contract

Compliance

• Support the execution of cell and gene therapy regulatory CMC strategies for marketed products
• Contributes to the planning, preparation and submission of regulatory CMC documentation
• Provides regulatory support and guidance to various cross functional teams
• Planning and execution of international regulatory CMC submissions, including creation of content plans
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory and technical colleagues to ensure timely submission and approval of CMC changes in the post approval environment
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations